The present invention relates to a stoma device and method which provide control over the discharge from a person's stoma.
The United Colostomy Association estimates that there are approximately one million people in the United States and Canada with stomas. Many of these people woule like to have the same control over gas and feces that a normal rectal sphincter affords. Numerous devices and methods have been proposed in an attempt to provide a solution to this problem, for example, the magnetic cap arrangement disclosed in U.S. Pat. No. 3,952,726, the spherical balloon type device disclosed in U.S. Pat. No. 2,564,399 and the annular closure disclosed in German Offenlegungsschrift No. 2,558,521. However, to date no stoma device or method has been able to accomplish the desired control over gas and feces that a normal rectal sphincter affords without posing serious problems, the most significant of which have been tissue destruction and discomfort. More specifically, such known devices and methods may be problematical because, for example, they require undue distension of the bowel, they place relatively high and potentially harmful pressure on the abdominal wall and/or the bowel, and because they must be dimensioned in length, for example, within relatively small tolerances to achieve control or closure of a stoma.
An object of the present invention is to provide a stoma control device and method which avoid the aforementioned disadvantages of the known devices. More particularly, an object of the present invention is to provide a stoma control device and method which provide continence and which do so with patient comfort as well as the absence of tissue damage. Further objects of the present invention include the provision of a stoma control device and method which do not require undue distension of the bowel, and which do not place relatively high and potentially harmful stresses on the abdominal wall or on the bowel, and wherein the length or dimensional tolerances for closure or control of a stoma are somewhat forgiving.
The above and other objects of the invention are attained by providing a stoma control device comprising, in combination, a support means for surgical implantation in the body beneath the abdominal wall and at least substantially around the emerging bowel of the stoma, the support means having an inner surface which is positioned adjacent the bowel on implantation, at least a portion of the inner surface being tapered outwardly, and plug means adapted to be received in the stoma and within the bowel, the plug including expandable means which, on expansion, presents an outer surface at least a portion of which is outwardly tapered with a shape which complements the outwardly tapered surface of the support means whereby during control of the stoma with the device a relatively large surface of the bowel may be gently compressed between the respective tapered surfaces of the plug means and the support means so as to minimize pressure and tissue destruction.
The outwardly tapered portion of the inner surface of the support means preferably extends over at least a major portion of the length of the support means and, according to a preferred embodiment of the invention disclosed herein, this outwardly tapered portion of the inner surface extends over substantially the entire length of the support means. This provides a relatively large supporting surface for the bowel. The area of the outwardly tapered portion of the inner surface of the support means is preferably at least approximately one and one-half times the minimum cross sectional area of the bowel supported thereon during control of the stoma with the device.
The outwardly tapered portion of the outer surface of the expandable means is preferably substantially equal in length or co-extensive with the outwardly tapered portion of the inner surface of the support means so that with the support means as referred to above, the bowel is compressed over at least a major portion of the length of the support means or, as in the disclosed embodiment, over substantially the entire length of the support means during control of the stoma with the device. Preferably the area of bowel compressed during control of the stoma with the device is at least approximately one and one-half times the minimum cross sectional area of the bowel compressed between the support means and the expandable means.
According to further features of the present invention, the plug means includes an outwardly directed flange adjacent one end and the expandable means adjacent the other end. In the disclosed embodiment of the invention the expandable means is an inflatable balloon. The plug means includes a valve means for inflation and deflation of the balloon, an air passage being provided in the plug means to communicate the balloon with the valve means. According to the disclosed embodiment of the invention, the valve means is in the form of a nipple valve which accepts a syringe for inflation and deflation of the balloon.
A further feature of the invention is that the expandable means is dimensioned such that during control of the stoma with the device preferably at least a major portion of the expandable means is positioned radially inwardly of the support means. In the disclosed embodiment of the invention, the expandable means is dimensioned such that during control of the stoma substantially all of the expandable means is positioned radially inwardly of the support means. Thus, on expansion of the expandable means the outwardly tapered portion of the outer surface of the expandable means moves radially outwardly to gently compress the bowel against the outwardly tapered surface of the support means. Such movement produces a wedging action of the plug means within the bowel and support means to seal or close the bowel or stoma and to prevent explusion of the plug means from the pressue within the bowel. Because the force necessary to create this wedging action and seal or closure of the bowel or stoma is distributed over a relative large surface of the bowel between the respective tapered surfaces of the plug means and the support means, the bowel need only be gently compressed during control or closure of the stoma with the device thereby minimizing pressure and tissue destruction.
The support means of the invention is formed of a relatively soft material such as a soft plastic. A medical grade silicone elastomer may be used. In one form of the invention the support means is a ring having a continuous circular form. According to another form of the invention the support means is a ring which is broken so as to allow placement around the bowel.
In the disclosed embodiment of the invention the respective tapered surfaces of the support means and the plug means have a linear taper and are in the form of truncated cones.
The method of controlling a stoma according to the present invention comprises surgically implanting a support means of the aforementioned type in the body beneath the abdominal wall and at least substantially around the emerging bowel of a stoma, inserting a plug means of the aforementioned type in the stoma and within the bowel, and expanding the expandable means to gently compress a relatively large surface of the bowel between the respective tapered surfaces of the plug means and the support means whereby pressure and tissue destruction are minimized during control of the stoma.